The US agency hopes that the new program will make information from device clinical trials more accessible to patients, caregivers and providers, including any benefits or risks more likely to occur in certain demographics.
Stakeholders will be able to get key information about device clinical trials through a new US Food and Drug Administration pilot program, Device Trial Participation Snapshots.
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An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
The Republic of Ireland’s record in life sciences is impressive. Decades of investment, education and training have been major winners for the country’s successful economy. But its success is drawing unwanted attention from the US. Trump wants “to have that.”
